Patient perspectives about participation in a chronic rhinosinusitis trial during the COVID pandemic: a qualitative study.

Key points

The NIHR-funded MACRO trial has been designed to evaluate endoscopic sinus surgery (ESS) and clarithromycin in the management of patients with chronic rhinosinusitis (CRS)¹. The trial opened to recruitment in 2018 and by March 2020 was actively recruiting at 15 ENT sites across the UK. The onset of the COVID pandemic brought about considerable changes to clinical services and NIHR prioritisation of COVID-19 research studies. Consequently, MACRO trial recruitment was paused. In May 2020, the NIHR published a framework to support the restart of research activities². Preconditions for restarting paused studies included careful consideration of research viability, research safety, and site capacity/readiness.

As part of getting ready to restart the MACRO trial, we recognised the importance of exploring the CRS patient perspective, with particular focus on their priorities, concerns and expectations for taking part in a clinical trial during the COVID period, and to identify strategies to minimise any potential anxieties around COVID safety.

We purposefully sampled 19 trial participants from 5 ENT recruitment sites in England to take part in a telephone interview. Participants had given consent to interview as part of the MACRO trial which received ethical approval from the North East - Newcastle & North Tyneside 2 Research Ethics Committee on 20th September 2018 (REC ref.: 18/NE/0210)³. Participants were contacted by email or telephone by a researcher to arrange a suitable time for interview. We included participants with a range of characteristics including age, gender, treatment group (ESS, clarithromycin, placebo), +/-nasal polyps and prior ESS. A topic guide was used to structure the interviews but also allowed exploration of particular topics that were important to the participants. We asked questions about their current views of CRS treatments, concerns about COVID, and potential barriers and facilitators to participating in the trial. The interviews were conducted between Nov 2000 and Feb 2021 by two experienced qualitative researchers (CM and SW) who were unknown to the participants. The average length of interview was 25 minutes. All interviews were audio-recorded and transcribed verbatim, and field notes captured contextual information. Data was managed using NVivo qualitative data analysis software⁴. We conducted a qualitative thematic analysis⁵ of the interview data (a method of detailed coding of the interview transcripts, and identifying themes through refining codes and discussing within the research team). We report the findings according to the COREQ (Consolidated criteria for Reporting Qualitative research) checklist⁶.

Table 1 presents the characteristics of the participants who took part in the study.

The findings of the study are presented in three themes: i) experiences of trial participation, ii) safety concerns, iii) facilitating the restart of the MACRO trial.

Participants’ reported mixed experiences of trial participation during the first 6 months of the pandemic. Some reported feeling well-supported by the clinical team, with good communication about the trial, their future care and how to contact the team if needed. “I can’t praise the process enough. I would certainly do another trial, and I wouldn’t think about it at all. (Participant 12, female, medical arm)

In contrast, other participants felt communication paused once the pandemic started, reporting that they felt confused or unclear about key aspects of the trial, and the management of their CRS. This included uncertainty about whether they had finished the trial; whether they were to expect further treatment, and whether to report any new medical problems or adverse events to the trial team.

“I realise that things are difficult obviously at the moment, and so that wouldn’t necessarily be seen by them as being a huge priority. On the other hand, what is the concluding step in the research? (Participant 6, male, surgical arm)

Most participants were understanding about the delays and reduced communication. However, participants who had experienced a return of their CRS symptoms or who were uncertain about their follow on treatment were particularly eager for communication to resume.

“I’ve a significant improvement, generally very happy, but would like a few more answers as to why I might have experienced a second loss of senses. (participant 13, male, surgical arm)

Whilst a third of the participants interviewed expressed no concern about participating in a trial during the COVID pandemic, the others described being unwilling to participate until the COVID risks reduced, or would need to weigh up the risks versus potential benefits.

Participants were most concerned about possible exposure to COVID from mixing with other members of the public, especially in the main hospital entrances and foyer, waiting areas and toilet areas. Participants expressed minimal confidence that other members of the public would adhere to social distancing or other COVID safety precautions.